[Federal Register: June 30, 2005 (Volume 70, Number 125)]
[Notices]
[Page 37861-37862]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30jn05-103]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004D-0118]
International Conference on Harmonisation; Guidance on Q5E
Comparability of Biotechnological/Biological Products Subject to
Changes in Their Manufacturing Process; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance entitled ``Q5E Comparability of
Biotechnological/Biological Products Subject to Changes in Their
Manufacturing Process.'' The guidance was prepared under the auspices
of the International Conference on Harmonisation of Technical
Requirements for Registration of Pharmaceuticals for Human Use (ICH).
The purpose of the guidance is to provide principles for assessing the
comparability of biotechnological/biological products before and after
changes are made in the manufacturing process for the drug substance or
drug product. The guidance is intended to assist in the collection of
relevant technical information that serves as evidence that the
manufacturing process changes will not have an adverse impact on the
quality, safety, and efficacy of the drug product.
DATES: Submit written or electronic comments on agency guidances at any
time.
ADDRESSES: Submit written comments on the guidance to the Division of
Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments
to http://www.fda.gov/dockets/ecomments. Submit written requests for
single copies of the guidance to the Division of Drug Information (HFD-
240), Center for Drug Evaluation and Research, Food and Drug
Administration, 5600 Fishers Lane, Rockville, MD 20857, or the Office
of Communication, Training, and Manufacturers Assistance (HFM-40),
Center for Biologics Evaluation and Research (CBER), Food and Drug
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448. The
guidance may also be obtained by mail by calling the CBER Voice
Information System at 1-800-835-4709 or 301-827-1800. Send one self-
addressed adhesive label to assist the office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.
FOR FURTHER INFORMATION CONTACT:
Regarding the guidance: Barry Cherney, Center for Drug Evaluation
and Research (HFD-122), Food and Drug Administration, 1401 Rockville
Pike, Rockville, MD 20852, 301-827-1790; or Andrew Chang, Center for
Biologics Evaluation and Research (HFM-340), Food and Drug
Administration, 1401 Rockville Pike, Rockville, MD 20852, 301-496-4833.
Regarding the ICH: Michelle Limoli, Office of International
Programs (HFG-1), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-4480.
SUPPLEMENTARY INFORMATION:
I. Background
In recent years, many important initiatives have been undertaken by
regulatory authorities and industry associations to promote
international harmonization of regulatory requirements. FDA has
participated in many meetings designed to enhance harmonization and is
committed to seeking scientifically based harmonized technical
procedures for pharmaceutical development. One of the goals of
harmonization is to identify and then reduce differences in technical
requirements for drug development among regulatory agencies.
ICH was organized to provide an opportunity for tripartite
harmonization initiatives to be developed with input from both
regulatory and industry representatives. FDA also seeks input from
consumer representatives and others. ICH is concerned with
harmonization of technical requirements for the registration of
pharmaceutical products among three regions: The European Union, Japan,
and the United States. The six ICH sponsors are the European
Commission; the European Federation of Pharmaceutical Industries
Associations; the Japanese Ministry of Health, Labour, and Welfare; the
Japanese Pharmaceutical Manufacturers Association; the Centers for Drug
Evaluation and Research and Biologics Evaluation and Research, FDA; and
the Pharmaceutical Research and Manufacturers of America. The ICH
Secretariat, which coordinates the preparation of documentation, is
provided by the International Federation of Pharmaceutical
Manufacturers Associations (IFPMA).
The ICH Steering Committee includes representatives from each of
the ICH sponsors and the IFPMA, as well as observers from the World
Health Organization, Health Canada, and the European Free Trade Area.
In the Federal Register of March 30, 2004 (69 FR 16580), FDA
published a notice announcing the availability of a draft tripartite
guidance entitled ``Q5E Comparability of Biotechnological/Biological
Products Subject to Changes in Their Manufacturing Process.'' The
notice gave interested persons an opportunity to submit comments by May
19, 2004.
After consideration of the comments received and revisions to the
guidance, a final draft of the guidance was submitted to the ICH
Steering Committee and endorsed by the three participating regulatory
agencies in November 2004.
The document provides guidance on the principles for assessing the
comparability of biotechnological/biological products before and after
changes are made in the manufacturing process for the drug substance or
drug product. The document does not prescribe any particular
analytical, nonclinical, or clinical strategy. The main focus of the
document is on quality aspects.
This guidance is being issued consistent with FDA's good guidance
practices regulations (21 CFR 10.115). The guidance represents the
agency's current thinking on Q5E comparability of biotechnological/
biological products subject to changes in their manufacturing process.
It does not create or confer any rights for or on any person and does
not operate to bind FDA or the public. An alternative approach may be
used if such approach satisfies the requirements of the applicable
statutes and regulations.
Note that FDA may have existing guidance on this or related topics,
such as ``FDA Guidance Concerning Demonstration of Comparability of
Human Biological Products, Including Therapeutic Biotechnology-derived
Products,'' available at http://www.fda.gov/cber/gdlns/comptest.txt.
[[Page 37862]]
II. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments on the guidance at any
time. Submit a single copy of electronic comments or two paper copies
of any mailed comments, except that individuals may submit one paper
copy. Comments are to be identified with the docket number found in
brackets in the heading of this document. The guidance and received
comments may be seen in the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday.
III. Electronic Access
Persons with access to the Internet may obtain the document at
http://www.fda.gov/ohrms/dockets/default.htm, http://www.fda.gov/cder/guidance/index.htm, or http://www.fda.gov/cber/reading.htm.
Dated: June 22, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-12908 Filed 6-29-05; 8:45 am]
BILLING CODE 4160-01-S